Balloon catheter, in particular for delivering drugs or stents in the region of a stenosis

• US 9,770,575 B2
• Filed: 10/27/2011
• Issued: 09/26/2017
• Est. Priority Date: 11/09/2010
• Status: Active Grant

• Current Assignee: Biotronik AG (Biotronik SE & Company KG)
• Original Assignee: Biotronik AG (Biotronik SE & Company KG)
• Inventors: Wesselmann, Matthias, Brunner, Tobias, Lang, Hans
• Primary Examiner(s): Price, Nathan R
• Assistant Examiner(s): LEE, WENG WAH
• Application Number:
  US13/283,050
• Publication Number:
  US 20120116490A1
• Time in Patent Office: 2,161 Days
• Field of Search: 604 9701, 60410302, 604104-109, 604913-921, 606191-200
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes

Abstract

A balloon catheter, in particular for delivering medicaments, stents or medicament-coated stents in the region of a stenosis, comprising

• • an outer shaft (4)
  • an inner shaft (6), and
  • a balloon (7) at the distal catheter end, which balloon is dilatable by a feedable pressure fluid and which is attached with its proximal end (8) to the outer shaft (4) and with its distal end (9) to the inner shaft (6) which protrudes the outer shaft (4) in the distal direction,
  • and
  • a cover sheath (15) which is seated in a covering position over the contracted balloon (7) and is displaceably guided on the outer shaft (4) and which is displaceable on the outer shaft (4) in the proximal direction via its front opening (17) by the dilating balloon (7) while continuously releasing the same from distal to proximal.

Claims

1. A balloon catheter comprising:

an outer shaft comprising a passage opening transverse to its length,

an inner shaft,

a balloon dilatable by a feedable pressure fluid through the outer shaft, wherein the proximal end of the balloon is attached to the outer shaft entirely distal to the passage opening to provide access to an intermediate space outside of the outer shaft without entering the balloon, further wherein the inner shaft protrudes from the outer shaft in a distal direction, and

a cover sheath which is seated in a covering position over the passage opening and the balloon when the balloon is contracted, wherein during dilation of the balloon the cover sheath seals against both the outer shaft and the balloon in a pressure-tight manner and the balloon emerges from a front opening at a distal end of the cover sheath to displaceably guide the cover sheath along the outer shaft in a proximal direction via its front opening, thereby continuously releasing the dilating balloon from distal to proximal,

wherein the intermediate space positioned between the cover sheath and the balloon communicates with a pressure fluid line to the balloon via the passage opening outside of the balloon.

2. The balloon catheter according to claim 1, characterized in that the intermediate space between the cover sheath and the balloon delivers pressurized fluid outside and proximal to the balloon to counteract wedging of the balloon against the sheath during dilation.

4. The balloon catheter according to claim 1, characterized in that the balloon is provided on its outer side with a medicament coating which can be released in the proximal direction by the dilatation of the balloon while displacing the cover sheath at the same time.

5. The balloon catheter according to claim 1, characterized in that a dead stop is arranged on the outer shaft for limiting the displacement path of the cover sheath in the proximal direction while maintaining the seals.

6. The balloon catheter according to claim 1, characterized in that the balloon is attached with its distal end via a cone body to the inner shaft.

7. The balloon catheter according to claim 6, characterized in that in the covering position of the cover sheath, an initial opening gap remains for the balloon between the front opening of the cover sheath and the cone body.

3. A balloon catheter loaded with a stent, comprising:

an outer shaft comprising a passage opening transverse to its length,

an inner shaft,

a balloon dilatable by a feedable pressure fluid through the outer shaft, wherein the proximal end of the balloon is attached to the outer shaft entirely distal to the passage opening to provide access to an intermediate space outside of the outer shaft without entering the balloon, further wherein the inner shaft protrudes from the outer shaft in a distal direction,

a cover sheath which is seated in a covering position over the passage opening and the balloon when the balloon is contracted, wherein during dilation of the balloon the balloon emerges from a front opening at a distal end of the cover sheath and displaceably guides the cover sheath along the outer shaft in a proximal direction via its front opening to continuously release the dilating balloon from distal to proximal, and

a stent arranged on the balloon, which stent is retained in its contracted state enclosed by the cover sheath in the covering position of the latter and can be automatically released by the dilatation of the balloon while displacing the cover sheath at the same time in the proximal direction,

wherein the intermediate space positioned between the cover sheath and the balloon communicates with a pressure fluid line to the balloon via the passage opening outside of the balloon.

8. The balloon catheter according to claim 3, characterized in that the balloon is provided on its outer side with a medicament coating which can be released in the proximal direction by the dilatation of the balloon while displacing the cover sheath at the same time.

9. The balloon catheter according to claim 3, characterized in that the balloon is attached with its distal end via a cone body to the inner shaft.

10. The balloon catheter according to claim 3, characterized in that a dead stop is arranged on the outer shaft for limiting the displacement path of the cover sheath in the proximal direction while maintaining the seals.

11. The balloon catheter according to claim 10, characterized in that in the covering position of the cover sheath, an initial opening gap remains for the balloon between the front opening of the cover sheath and the cone body.